Ex Parte Nycz et alDownload PDFBoard of Patent Appeals and InterferencesNov 17, 201111048064 (B.P.A.I. Nov. 17, 2011) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 11/048,064 02/02/2005 Jeffrey H. Nycz PC1017.00 2263 71998 7590 11/17/2011 Medtronic Attn: Noreen Johnson - IP Legal Department 2600 Sofamor Danek Drive Memphis, TN 38132 EXAMINER WILSON, MICHAEL C ART UNIT PAPER NUMBER 1632 MAIL DATE DELIVERY MODE 11/17/2011 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte JEFFREY H. NYCZ and JON C. SERBOUSEK __________ Appeal 2011-006654 Application 11/048,064 Technology Center 1600 __________ Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to methods of treating an osteolytic lesion. The Patent Examiner rejected the claims for containing new matter and for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2011-006654 Application 11/048,064 2 STATEMENT OF THE CASE Claims 31-36 and 52 are on appeal. Claim 35 is representative and reads as follows: 35. A method of treating an osteolytic lesion comprising: accessing the osteolytic lesion located at an interface between a patient's bone and an orthopedic prosthetic by inserting a cannula or guidewire through a passageway, wherein the osteolytic lesion is caused by particulate induced bone resorption; preparing the osteolytic lesion for receiving a bone growth promoting substance by debriding a surface of the osteolytic lesion using a debriding device; and delivering the bone growth promoting substance to the osteolytic lesion via a delivery apparatus selected from a cannula or graft syringe, wherein the bone growth promoting substance is capable of adhering to the osteolytic lesion and comprises: a carrier and at least one or more osteoinductive agents selected from the group consisting of one or more BMPs, one or more VEGFs, one or more CTGFs, osteoprotegerin, one or more TGF-betas, and any combination thereof. The Examiner rejected the claims as follows: 1 • claims 31-36 and 52 under 35 U.S.C. § 112, first paragraph, on the grounds that “accessing the osteolytic lesion… by inserting a cannula or guidewire through a passageway” is new matter; and • claims 35 and 36 under 35 U.S.C. § 103(a) as unpatentable over Tompkins, 2 Maloney, 3 or Lavernia, 4 in view of Wang 5 and Glowa; 6 1 The Examiner withdrew the rejection of claims 35, 36, and 41 under 35 U.S.C. § 103(a) as unpatentable over Tompkins, Maloney, or Lavernia, in view of Wang, Glowa, and Petersen because claim 41 was cancelled. (Ans. 3-4.) 2 Geoffrey S. Tompkins, M.D., et al., Primary Total Hip Arthroplasty with a Porous-Coated Acetabular Component, 79 J. OF BONE AND JOINT SURGERY 169-176 (1997). Appeal 2011-006654 Application 11/048,064 3 • claims 31, 32, 34, 35, and 36 under 35 U.S.C. § 103(a) as unpatentable over Tompkins, Maloney, or Lavernia, in view of Wang and Glowa, and further in view of Ferrara, 7 Aggarwal, 8 or Grotendorst; 9 • claims 33, 35, 36, and 52 10 under 35 U.S.C. § 103(a) as unpatentable over Tompkins, Maloney, or Lavernia, in view of Wang, Glowa, and Boyle. 11 CLAIM INTERPRETATION Based on the arguments presented, the Examiner and Appellants have differing opinions about whether the claimed methods limit accessing the osteolytic lesion through a “minimally invasive technique.” Appellants 3 William J. Maloney, M.D., et al., Treatment of Pelvic Osteolysis Associated with a Stable Acetabular Component Inserted without Cement as Part of a Total Hip Replacement, 79 J. OF BONE AND JOINT SURGERY 1628- 1634 (1997). 4 Carlos J. Lavernia, M.D., et al., Arthroscopic Shaver-Assisted Total Hip Arthroplasty Revision, 13 J. OF SURGICAL ORTHOPAEDIC ADVANCES 174-176 (2004). 5 Jeffrey C. Wang, M.D., et al., Effect of Regional Gene Therapy with Bone Morphogenetic Protein-2-Producing Bone Marrow Cells on Spinal Fusion in Rats, 85-A J. OF BONE AND JOINT SURGERY 905-911 (2003). 6 US Patent No. 5,779,697 issued to Michael P. Glowa et al., Jul. 14, 1998. 7 US Patent No. 6,455,283 B1 issued to Napoleone Ferrara et al., Sep. 24, 2002. 8 US Patent No. 6,998,383 B2 issued to Bharat Aggarwal et al., Feb. 14, 2006. 9 US Patent No. 5,837,258 issued to Gary R. Grotendorst, Nov. 17, 1998. 10 The Examiner “newly rejected” claim 52, stating “[i]t is obvious that claim 52 was inadvertently omitted from the final rejection because all the limitations in claim 52 (specifically osteoprotegerin) were addressed in the body of the rejection.” (Ans. 4, 14.) 11 US Patent No. 6,015,938 issued to William J. Boyle et al., Jan. 18, 2000. Appeal 2011-006654 Application 11/048,064 4 assert that “it is clear that the claims have been limited to the preferred embodiment described with reference to Figures 1 and 2 – a minimally invasive technique,” i.e., “using a cannula or guidewire.” (App. Br. 3-4.) The Examiner‟s position is that the claimed method step of accessing the lesion is not limited to using minimally invasive techniques, but rather may also include “conventional open surgical techniques.” (Ans. 2, 6.) In particular, the Examiner‟s interpretation is that “the claims reasonably encompass accessing an osteolytic lesion by inserting a cannula or guidewire „through a passageway‟ [that is] made using „open procedures‟ or „minimally invasive techniques.‟” (Id. at 3.) Findings of Fact 1. The claims do not recite the phrase “minimally invasive procedure.” 2. The claims do not limit or otherwise recite how the “passageway” through which the cannula or guidewire is inserted is created. 3. The Specification states that the bone defect can be accessed “using conventional open surgical techniques” and also “by inserting a cannula 200 (or guidewire, not shown) through the skin 120 and soft tissue 130.” (Spec. [0038]-[0039].) 4. The Specification states that “[i]n a preferred embodiment, accessing the bone defect can be accomplished in any number of minimally invasive methods known in the art ….” (Id. at [0039].) 5. The Specification does not explicitly state that accessing the osteolytic lesion by inserting a cannula or guidewire through a passageway may not be accomplished in a conventional open surgical technique. Appeal 2011-006654 Application 11/048,064 5 Principles of Law “[D]uring examination proceedings, claims are given their broadest reasonable interpretation consistent with the specification.” In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000). “Absent claim language carrying a narrow meaning, the PTO should only limit the claim based on the specification or prosecution history when those sources expressly disclaim the broader definition.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). “[W]hile it is true that claims are to be interpreted in light of the specification . . . , it does not follow that limitations from the specification may be read into the claims . . . . It is the claims that measure the invention.” Sjolund v. Musland, 847 F.2d 1573, 1581-82 (Fed. Cir. 1988) (emphasis in original, citation omitted). Discussion We agree with Appellants that the Specification Figure 1 illustrates a cannula inserted through the skin and soft tissue and that the Specification states that “[t]he bone defect 100 can be accessed by inserting a cannula 200…or guidewire… through the skin 120 and soft tissue 130.” (App. Br. 3-4; FF-3.) We also agree that this technique may be considered one of the preferred embodiments involving “minimally invasive methods” referred to in the Specification. (FF-4.) However, unlike these statements in the Specification, the claimed methods do not recite the phrase “minimally invasive” methods, procedures or techniques. (FF-1.) Nor do the claimed methods require inserting a cannula or guidewire “through the skin and soft tissue.” Rather, the claims broadly recite that the osteolytic lesion is accessed “by inserting a cannula or guidewire through a passageway.” (Claim 35, emphasis added.) The claims do not recite any limitation as to Appeal 2011-006654 Application 11/048,064 6 the method, procedure or technique by which this “passageway” is created (FF-2) and we do not read limitations from the Specification into the claims. See Sjolund v. Musland, 847 F.2d at 1581-82. “It is the claims that measure the invention.” Id. Therefore, we conclude that the claimed methods encompass “inserting a cannula or guidewire through a passageway,” wherein the passageway may be achieved using conventional open surgical or minimally invasive techniques. See Bigio, 381 F.3d at 1325. NEW MATTER The Issue The Examiner‟s position is that the Specification describes accessing a bone defect “„using conventional open surgical techniques‟” and explains that a preferred embodiment for accessing a bone defect is “minimally invasive.” (Ans. 6.) The Examiner found that “„accessing the osteolytic lesion…by inserting a cannula or guid[ewire] through a passageway‟” has a different scope than accessing the lesion using conventional open surgical techniques or by minimally invasive techniques. (Id.) According to the Examiner, “[i]t is not readily apparent applicants contemplated the breadth of accessing the osteolytic lesion by inserting a cannula or guidewire through passageway as now claimed” because accessing a lesion in this manner “is not implicit from the concept of accessing a bone defect using conventional open surgical techniques… or by minimally invasive techniques … as originally contemplated by applicants.” (Id.) Appellants contend that the claims are fully supported by the Specification, particularly paragraphs [0038]-[0040] which “refer[] to a minimally invasive surgical procedure for accessing a bone defect by inserting a cannula 200 or guidewire….” (App. Br. 11.) Appeal 2011-006654 Application 11/048,064 7 The issue is whether the Specification reasonably conveyed to a person of ordinary skill in the art that the inventors had possession of methods comprising accessing an osteolytic lesion by “inserting a cannula or guidewire through a passageway.” Findings of Fact 6. The Specification states that Figure 1 illustrates “a bone having a bone defect, together with the adjacent tissue and a cannula inserted through the tissue to a position adjacent the bone defect.” (Spec. [0016].) 7. The Specification states that Figure 2 illustrates “the bone and bone defect of Figure 1 with the access apparatus [i.e., cannula] having dilated the adjacent tissue to provide access to the bone defect.” (Id. at [0017].) 8. The Specification states that “[t]he bone defect 100 can be accessed by inserting a cannula 200 (or guidewire, not shown) through the skin 120 and soft tissue 130.” (Id. at [0039].) Principles of Law The test for determining compliance with the written description requirement is whether the disclosure of the application as originally filed reasonable conveys to the artisan that the inventor had possession at the time of the later claimed subject matter, rather than the presence or absence of literal support in the specification for the claim language. In re Kaslow, 707 F.2d 1366, 1375 (Fed. Cir. 1983). Analysis We agree with Appellants that the Examiner has not established that the claim phrase “inserting a cannula or guidewire through a passageway” introduces new matter into the application disclosure. Rather, the Specification as originally filed expressly disclosed this matter. (See FF-6, Appeal 2011-006654 Application 11/048,064 8 7, 8.) Thus, a skilled artisan would have understood that the inventors had possession of the subject matter in question at the time the present application was filed. See Kaslow, 707 F.2d at 1375. We reverse the new matter rejection. OBVIOUSNESS The Issue The Examiner‟s position is that Tompkins, Maloney and Lavernia each taught a method of “treat[ing] osteolytic lesions at an interface between a patient‟s bone and an orthopedic prosthetic by a) making an incision in the skin and tissue, b) accessing the osteolytic lesion, c) debriding the surface of the lesion, and d) delivering a bone graft.” (Ans. 7-8.) The Examiner found that the “osteolytic lesions of Tompkins, Maloney and Lavernia were implicitly accessed by creating a passageway through the patient‟s skin and tissue as claimed because they were debrided and grafted.” (Id. at 8.) According to the Examiner, “[t]he only way to debride and graft an osteolytic lesion is by making a passageway th[r]ough the skin and tissue to the osteolytic lesion.” (Id.) Moreover, the Examiner found that the osteolytic lesions of Tompkins and Maloney “were implicitly accessed using a cannula as claimed because they were debrided and grafted.” (Id.) According to the Examiner, “[d]ebriding must have required a tube for inserting the debriding instrument, and grafting must have required some sort of tube for delivery of the graft.” (Id.) Additionally, the Examiner found that Lavernia “implicitly accessed” its osteolytic lesions “by arthroscopy which requires an arthroscope which is equivalent to a cannula.” (Id.) Appeal 2011-006654 Application 11/048,064 9 Further, the Examiner found that “[i]f the osteolytic lesions of Tompkins, Maloney and Lavernia were not accessed using a cannula as claimed, arthroscopic cannulas were well known in the art at the time of filing,” as evidenced by Glowa. (Id.) According to the Examiner, “[a]ccessing osteolytic lesions with a cannula or guidewire was well within the [purview] of those of ordinary skill in the art at the time of filing as evidenced by Lavernia and Glowa.” (Id.) Additionally, the Examiner found that “Tompkins, Maloney and Lavernia did not teach deliver[ing] a polynucleotide encoding BMP, VEGF, CTGF, osteoprotegerin, TGF-β, or a combination thereof to the lesion.” (Id. at 9.) However, the Examiner found that Wang disclosed “deliver[ing] bone marrow cells comprising adenovirus encoding BMP-2 with demineralized bone matrix (DMB) or collagen sponge (Groups I and II) to a vertebrae of the lumbar spine that had been decorticated using a speed burr.” (Id.) The Examiner also found that the defect made by Wang was a lesion in the bone and therefore modeled osteolysis at an interface between bone and an orthopedic implant. (Id. at 10.) According to the Examiner, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to treat an osteolytic lesion at an interface between a patient‟s bone and an orthopedic prosthetic comprising accessing the lesion using arthroscopy, as described by Tompkins, Maloney and Lavernia, and further comprising delivering bone marrow cells comprising adenovirus encoding BMP-2 to the osteolytic lesion, as described by Wang. (Id.) Regarding claims 31, 32, 34, 35, and 36, the Examiner further found that the “combined teachings of Tompkins, Maloney, Lavernia, Wang and Appeal 2011-006654 Application 11/048,064 10 Glowa did not teach delivering CTGF, VEGF or TGF.” (Id. at 12.) However, the Examiner found that treating bone defects with these growth factors was known in the art at the time of the invention, as evidenced by Ferrara, Aggarwal and Grotendorst. (Id.) According to the Examiner, a skilled artisan would have been motivated to replace BMP-2 in the combination with these growth factors because they were known to promote bone tissue growth. (Id.) Regarding claims 33, 35, 36 and 52, the Examiner further found that the “combined teachings of Tompkins, Maloney, Lavernia, Wang and Glowa did not teach delivering osteoprotegerin.” (Id. at 14.) However, the Examiner found that treating bone defects with osteoprotegerin was known in the art at the time of the invention, as evidenced by Boyle. (Id.) According to the Examiner, a skilled artisan would have been motivated to replace BMP-2 in the combination with osteoprotegerin because osteoprotegerin was known to promote bone tissue growth. (Id.) Appellants contend that Tompkins, Maloney and Lavernia did not teach or suggest accessing the osteolytic lesion by “inserting a cannula or guidewire through a passageway” as claimed. (App. Br. 16-18.) Further, according to Appellants, each of these references taught away from doing so because the disclosed surgical procedures involved replacing liners that could not be performed using a cannula. (Id. at 16-17.) The issue is whether the record supports the Examiner‟s finding that Tompkins, Maloney and Lavernia each implicitly taught or suggested accessing an osteolytic lesion by “inserting a cannula or guidewire through a passageway,” or alternatively, the Examiner‟s conclusion that doing so would have been obvious in view of Glowa. Appeal 2011-006654 Application 11/048,064 11 Findings of Fact 9. Tompkins described a hip that needed a reoperation for a problem involving the acetabular component. (Tompkins 172.) 10. Tompkins described performing debridement and grafting of an area of massive retroacetabular osteolysis. (Id.) 11. Maloney described “treat[ing] problems related to a porous-coated acetabular component that had been inserted without cement during a total hip arthroplasty” performed because pelvic osteolysis had developed. (Maloney 1629.) 12. Maloney explained that the “revision consisted of exchange of the polyethylene liner; débridement of the osteolytic lesion; and in some patients, bone grafting.” (Id.) 13. Lavernia is a journal article entitled “Arthroscopic Shaver-Assisted Total Hip Arthroplasty Revision” and describes a revision arthroplasty to treat an osteolytic lesion on the left acetabular region in a patient who previously had a hip replacement. (Lavernia 174.) 14. The Examiner found that Lavernia accessed the osteolytic lesion by arthroscopy. (Ans. 7-8, citing Lavernia 174, paragraph bridging cols. 1-2.) 15. The paragraph of Lavernia that the Examiner cited does not explicitly disclose accessing the osteolytic lesion by arthroscopy. (See Lavernia 174, paragraph bridging cols. 1-2.) 16. The Examiner found that “[a]n arthroscopic shaver implicitly requires arthroscopy, i.e. an arthroscope, i.e., a cannula or guidewire.” (Ans. 17.) 17. Glowa disclosed an arthroscopic cannula. (Glowa Abstract.) Appeal 2011-006654 Application 11/048,064 12 Principles of Law The question of obviousness is resolved on the basis of underlying factual determinations including (1) the scope and content of the prior art, (2) any differences between the claimed subject matter and the prior art, (3) the level of skill in the art, and (4) where in evidence, so-called secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17 (1966). A conclusion that the claimed subject matter is prima facie obvious must be supported by evidence, as shown by some objective teaching in the prior art or by knowledge generally available to one of ordinary skill in the art that would have led that individual to arrive at the claimed invention. See In re Fine, 837 F.2d 1071, 1074 (Fed. Cir. 1988). Analysis The claimed methods require “inserting a cannula or guidewire through a passageway….” (See Claims 35 and 52.) We agree with the Examiner (Ans. 8) that Tompkins and Maloney each described debriding and grafting an osteolytic lesion (see FF-10, 12.) For each of the rejections, the Examiner further finds that Tompkins and Maloney “implicitly” accessed the osteolytic lesion by using a cannula. (Ans. 8.) According to the Examiner, “[d]ebriding must have required a tube for inserting the debriding instrument, and grafting must have required some sort of tube for delivery of the graft.” (Id.) However, this reasoning is speculative and unsupported by the record evidence. Consequently, we agree with Appellants (App. Br. 15) that the Examiner has not properly determined “the scope and content” of Tompkins and Maloney, as required to resolve a question of obviousness. See Graham v. John Deere Co., 383 U.S. at 17. Appeal 2011-006654 Application 11/048,064 13 Additionally, for each of the rejections, the Examiner found that Lavernia “implicitly” accessed the osteolytic lesion by using a cannula “because Lavernia specifically [taught that] the lesions were accessed by arthroscopy which requires an arthroscope which is equivalent to a cannula.” (Ans. 8.) Appellants acknowledge that Lavernia inserted an arthroscopic shaver through holes drilled in the acetabular cup, but contend Lavernia used an “open procedure,” which their method does not. (App. Br. 17.) That argument is unpersuasive because “open” procedures are not disclaimed and because there is no significant difference between inserting the arthroscopic device through a drilled hole and the claimed method of inserting a device through a passageway. More persuasive are Appellants‟ contentions concerning the difference between Lavernia‟s shaver and the cannula or guidewire used in the claimed method. The Examiner found that Lavernia accessed the osteolytic lesion by arthroscopy, but the paragraph of Lavernia that the Examiner cited does not disclose accessing the osteolytic lesion by arthroscopy. (FF-14, 15.) Therefore, the Examiner‟s finding is not supported by explicit evidence. The Examiner argues that “[a]n arthroscopic shaver implicitly requires arthroscopy, i.e., an arthroscope, i.e., a cannula or guidewire” (FF-16), but the Examiner provides no evidence to support this disputed finding. Thus, the Examiner‟s reasoning is again speculative and unsupported by the record evidence. Consequently, we agree with Appellants (App. Br. 15) that the Examiner has also not properly determined “the scope and content” of Lavernia, as required to resolve a question of obviousness. See Graham v. John Deere Co., 383 U.S. at 17. Alternatively, the Examiner found that “[i]f the osteolytic lesions of Tompkins, Maloney and Lavernia were not accessed using a cannula as Appeal 2011-006654 Application 11/048,064 14 claimed, arthroscopic cannulas were well known in the art,” as evidenced by Glowa. (Ans. 8.) According to the Examiner, “[a]ccessing osteolytic lesions with a cannula or guidewire was well within the [purview] of those of ordinary skill in the art at the time of filing as evidenced by Lavernia and Glowa.” (Id.) We agree with the Examiner that Glowa provides evidence that arthroscopic cannulas were well known in the art at the time of the invention. (FF-17.) However, the Examiner has not established that Lavernia‟s shaver and/or Glowa‟s disclosure suggested using cannulas to access osteolytic lesions, nor has the Examiner provided any additional evidence that such use would have been obvious to the skilled artisan at the time of the invention. See Fine, 837 F.2d at 1074. Accordingly, we reverse the obviousness rejections. CONCLUSIONS OF LAW The Specification reasonably conveyed to a person of ordinary skill in the art that the inventors had possession of methods comprising accessing an osteolytic lesion by “inserting a cannula or guidewire through a passageway.” The record does not support the Examiner‟s finding that Tompkins, Maloney and Lavernia each implicitly taught or suggested accessing an osteolytic lesion by “inserting a cannula or guidewire through a passageway,” and the record does not support the Examiner‟s conclusion that doing so would have been obvious in view of Glowa. Appeal 2011-006654 Application 11/048,064 15 SUMMARY We reverse the rejection of claims 31-36 and 52 under 35 U.S.C. § 112, first paragraph, on the grounds that “accessing the osteolytic lesion… by inserting a cannula or guidewire through a passageway” is new matter; we reverse the rejection of claims 35 and 36 under 35 U.S.C. § 103(a) as unpatentable over Tompkins, Maloney, or Lavernia, in view of Wang and Glowa; we reverse the rejection of claims 31, 32, 34, 35, and 36 under 35 U.S.C. § 103(a) as unpatentable over Tompkins, Maloney, or Lavernia, in view of Wang, Glowa, Ferrara, Aggarwal, and Grotendorst; and we reverse the rejection of claims 33, 35, 36, and 52 under 35 U.S.C. § 103(a) as unpatentable over Tompkins, Maloney, or Lavernia, in view of Wang, Glowa, and Boyle. REVERSED cdc Copy with citationCopy as parenthetical citation